Circulatory disturbances can lead to illness with bleedings or thrombi, clinical conditions which are denoted haemophilia or thrombophilia, respectively. Such disturbances may result from perturbations in the ability of the blood to coagulate or to dissolve coagulated material or from perturbations of the balance between these. Coagulum formation and coagulum dissolution are both precisely regulated processes, both of which can be regarded as composed of a driving and a restraining part. The coagulum-forming process is called coagulation and is hence a balance between pro-coagulative and anti-coagulative activities. Analogously, the coagulum dissolving process is called fibrinolysis and displays a pro-fibrinolytic and an anti-fibrinolytic part. The balance between coagulation and fibrinolysis is denoted haemostasis, which thus comprises all processes that prevent leakage of blood from the circulatory tract and which keep these open. The two concepts circulatory disturbances and haemostatic disturbances are in this context practically synonymous.
The understanding of haemophilia and the development of effective treatments for this condition has been strongly dependent on simple global functional laboratory methods, which have revealed altered coagulative properties of blood and blood plasma from the individuals in question. The principle of these methods is to add, to blood or blood plasma, reagents that trigger coagulation, and to register the reaction time necessary for a certain coagulum formation. Abnormally slow or weak coagulum formation has been characteristic of haemophilia, and medical treatments which have normalized the analytically determined values have proved to be effective in the alleviation of the clinical symptoms of the disease.
According to the above described view on hemostasis, the outlined prior art global functional laboratory methods for the characterizaton of coagulative activity are primarily sensitive to pro-coagulative disturbances. The methods have, however, appeared to be fairly satisfactory for the diagnosis of haemophilia because the haemostatic disturbances involved are often localized precisely to the pro-coagulative part of haemostasis. However, the prior art global methods cannot reveal disturbances in all haemophiliacs, and they are practically of no use for thrombophilia. This may be due to the fact that the methods do not give any indication, or only slight indication, of disturbances in the anti-coagulative part of the coagulation process, and that they lack sensitivity to fibrinolytic disturbances. The lack of or the need of a more comprehensive method, useful in practice, for analyzing or detecting coagulative, fibrinolytic and haemostatic properties of blood and blood plasma, is therefore obvious. A simple and especially a more reliable method relating to global haemostasis would doubtless result in improved diagnostics, improved treatment and more efficient development of methods of treatment, especially of thrombophilia. The present invention provides an improved global laboratory method of diagnostic analysis of coagulative, fibrinolytic or haemostatic properties of blood and blood plasma. Moreover, the method is of such nature that it is directly applicable to corresponding analysis of other biological fluids wherein such activities are present, for example synovial fluid and brain liquor.